Sunday, May 17, 2009

Vioxx: Australia trial - deja vu

Tufts University cardiologist Marvin Konstam

was lead author but made made "no significant contribution"

to a Merck-financed 2001 article in a leading journal that discounted

Vioxx health risks.

The Australian, a leading daily newspaper - and Wall Street Journal affiliate - has excellent coverage of the current Vioxx trial there. There are many demonstrations of marketing's triumph over science like those familiar to me from my work for plaintiffs in McDarby v. Merck: the hard sell, the misleading marketing, the wining and dining of doctors, the struggle with regulators. The Australian's index page for Vioxx is here

The current Vioxx trial in Federal Court replicates in may ways the U.S. experience: Merck struggling - with considerable success - to get regulators to soften the warnings, pointing to and developing the ambiguities in the medical evidence.

It is a much easier thing than one might think. Scientists are so imbued with fealty to the null hypothesis that it is rare to see them state a conclusion with any definiteness. Evidence always suggests, never shows, never proves. Thus

"On the witness stand yesterday, Mr Back (of Merck) admitted the company "pushed back" on the wording of the suggested warnings by the TGA in the product information, which was aimed at doctors.

"The company didn't believe (the warning) was supported by the data," he said.

When Mr Back, who is now the company's associate director of regulatory affairs, was asked by Mr Burnside who the warnings had to be made "palatable" for, he said it was for Ms Loran (a Merck marketing exec in the U.S.).

The court heard that the TGA finally accepted the revisions in November 2001 after Merck successfully changed the warning from Vioxx-specific to just referring to the class of drug.

Lead plaintiff Graeme Peterson, representing more than 1000 other Australians, claims Vioxx caused his heart attack in 2003. He is suing Merck & Co and Merck, Sharp and Dohme for compensation."

For excellent discussion of the issues, take a look at Concurring Opinion for its discussion of "mercketing". And for the particularly serious problem of pharmaceutical companies like Merck's ghost-writing medical literature, see Sergio Sismondo's Ghosts in the Machine.